[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611542":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":45,"locations":51,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"sirolimus (albumin-bound)+ DP303c","EXPERIMENTAL",null,[13,14],"Drug: sirolimus (albumin-bound)","Drug: DP303c",{"label":16,"type":10,"description":11,"interventionNames":17},"sirolimus (albumin-bound)+ SYS6043",[13,18],"Drug: SYS6043",{"label":20,"type":10,"description":11,"interventionNames":21},"sirolimus (albumin-bound)+ SYS6002",[13,22],"Drug: SYS6002",{"label":24,"type":10,"description":11,"interventionNames":25},"sirolimus (albumin-bound)+ SYS6010",[13,26],"Drug: SYS6010",[28,33,36,39,42],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","sirolimus (albumin-bound)","intravenous infusion",[9,20,24,16],{"type":29,"name":34,"description":31,"armGroupLabels":35,"otherNames":11},"DP303c",[9],{"type":29,"name":37,"description":31,"armGroupLabels":38,"otherNames":11},"SYS6043",[16],{"type":29,"name":40,"description":31,"armGroupLabels":41,"otherNames":11},"SYS6002",[20],{"type":29,"name":43,"description":31,"armGroupLabels":44,"otherNames":11},"SYS6010",[24],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",[52],{"facility":53,"status":54,"city":55,"state":11,"zip":11,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":59,"coordinates":60},"Point",[61,62],121.45806,31.22222,{"lat":62,"lon":61},[65],{"name":66,"role":48,"phone":11,"phoneExt":11,"email":67},"Jian Zhang","syner2000@163.com",{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100611542","phase-1-a-study-of-sirolimus-albumin-bound-in-combination-with-different-adcs-treatment-of-advanced-solid-tumors-100611542",false,"NCT07241936","A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors","A Phase Ib\u002FII Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Subjects aged 18 to 75 years (inclusive).\n* 2\\. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.\n* 3\\. At least one measurable lesion, as defined by RECIST 1.1 criteria.\n* 4\\. ECOG performance status of 0 or 1.\n* 5\\. Expected survival ≥ 3 months.\n* 6\\. Adequate function of major organs and bone marrow.\n* 7\\. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.\n* 8\\. Women or man of childbearing potential must use highly effective contraception.\n* 9\\. Able to understand and voluntarily sign the written informed consent form (ICF).\n\nExclusion Criteria:\n\n* 1\\. Previous use of antibody-conjugated drugs with similar loading agents for treatment.\n* 2\\. Previous anti-tumor treatment drugs were not adequately removed.\n* 3\\. Active leptomeningeal disease or uncontrolled CNS metastasis.\n* 4\\. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.\n* 5\\. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease\u002Fnon-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia\u002Flung disease.\n* 6\\. Patients who developed severe and moderately severe lung diseases that significantly affected lung function within 6 months of the first medication administration; patients requiring supplementary oxygen therapy.\n* 7\\. Individuals who currently have eye diseases such as corneal disorders, retinal disorders, or active ocular infections that require intervention, or who have a history of serious corneal-related eye diseases in the past; or who are unwilling to stop wearing corneal contact lenses during the study; or who have other existing eye diseases that affect the assessment of ocular toxicity after the administration of the investigational drug.\n* 8\\. Currently suffering from skin diseases that require oral or intravenous medication treatment.\n* 9\\. Had a history of ulcerative colitis or Crohn's disease.\n* 10\\. Within 14 days prior to the first administration of the medication, there is a need for systemic antibacterial, antifungal or antiviral treatment for severe chronic or active infections, and there is no cure for active tuberculosis.\n* 11\\. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product.\n* 12\\. Participants with poor compliance.","ALL","18 Years","75 Years",{"count":81,"type":82},444,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c\u002FSYS6043\u002FSYS6002\u002FSYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).",[89],"Advanced Solid Tumors","2025-11-21",{"date":92,"type":93},"2025-11-28","ACTUAL",{"date":95,"type":93},"2025-11-13",{"date":97,"type":82},"2028-10-30",{"name":5,"class":6},1]